Subcutaneous implantation tools and methods of implanting a subcutaneous device using the same. The tool may include a tool body having a longitudinally extending recess having a distal opening and having a tunneler at a distal end of the tool body extending from the distal opening of the recess. The tool may include a plunger slidably fitting within at least a portion of the tool body recess. The recess may be configured to receive an implantable device and the tunneler preferably extends distally from the recess at a position laterally displaced from the device when the device is so located in the recess. Movement of the plunger distally within the recess advances the device distally out of the recess and alongside of and exterior to the tunneler.

A method and apparatus are disclosed for a catheter having a side-port through which a wire may be advanced. The catheter comprises a catheter body, the catheter body defining at least a primary catheter lumen and at least one side-port in communication with the primary catheter lumen, and a distal portion of the catheter extending distal to the at least one side-port, the side-port being configured to allow travel of a wire or other component therethrough, wherein the distal portion of the catheter is radially collapsible.

A tunneling tool for forming a tissue channel and/or pocket beneath a portion of skin along a body comprises a distal end having a tunneling member and a guide. The tunneling member is configured for forming the tissue channel and/or pocket beneath the portion of skin while the guide remains above the skin and indicates the location of at least a portion of the tunneling member. An anchor for securing an elongate device to body tissue comprises an anchor body configured to receive the elongate device; a mechanism configured to removably attach the anchor body to the elongate device so as to resist movement of the elongate device in relation to the anchor body; and at least one tissue engagement element configured to assist in attaching the anchor body to the body tissue.

Insertion tools for medical applications. An illustrative example is an insertion tool for implanting a lead such as a subcutaneous defibrillation lead, which includes a handle at a proximal end, a catheter, and a distal end. A plurality of stylets having dottering tips are provided in the insertion tool. Reciprocating action of the dottering tips and/or stylets is imparted to dissect through subcutaneous tissue and create a tunnel for implantation of the lead.

A method for implanting a medical lead. The method includes advancing a tunneling tool posteriorly proximate the caudal end of the sternum toward a first location. The tunneling tool is advanced superiorly underneath the sternum through the anterior mediastinum from the first location to a second location cranial to the first location. A guidewire is advanced from the first location to the second location. A medical lead is slid along at least a portion of the guidewire, the medical lead at least substantially spanning the distance between the first location and the second location.

An epidural space is cleared of fat and scar tissue in preparation for implantation of a medical lead by utilizing a clearing tool. The clearing tool has an outer body and an inner body present within a lumen of the outer body. The outer body may be malleable and have a pre-set deflection or may be flexible and achieve deflection when being inserted into the epidural space. Once in the epidural space, the inner body is extended distally from the lumen of the outer body such that a distal tip on the inner body extends further into the epidural space to provide clearing to the target site without requiring further ingress of the outer body. The inner body is retracted and the clearing tool is removed. The medical lead is then inserted through the window and cleared epidural space until reaching the target site.

An epidural space is cleared of fat and scar tissue in preparation for implantation of a medical lead by utilizing a clearing tool. The clearing tool has an outer body and an inner body present within a lumen of the outer body. The outer body may be malleable and have a pre-set deflection or may be flexible and achieve deflection when being inserted into the epidural space. Once in the epidural space, the inner body is extended distally from the lumen of the outer body such that a distal tip on the inner body extends further into the epidural space to provide clearing to the target site without requiring further ingress of the outer body. The inner body is retracted and the clearing tool is removed. The medical lead is then inserted through the window and cleared epidural space until reaching the target site.

In one aspect, a tunneling tool for creating a subcutaneous pocket below a skin surface is provided. The tunneling tool may include a handle, a rod, a first prong, and a second prong. The rod and the first and second prongs may extend from a first end of the handle. The rod may extend farther from the first end of the handle than the first and second prongs and be configured to create the subcutaneous pocket. The first and second prongs may be configured to limit the depth at which the rod is capable of creating the subcutaneous pocket. The first and second prong may comprise first and second length indicators, respectively, configured to indicate a length of the subcutaneous pocket formed by the rod. In another aspect, a method of creating a subcutaneous pocket using the tunneling tool is provided.

A reservoir of a system for deploying an implantable lead to an extravascular location delivers a flow of fluid through a lumen of one or both of a tunneling tool and an introducer of the system. In some cases, the tunneling tool includes a pressure sensor assembly for monitoring a change in a pressure of the flow through the lumen thereof Alternately, or in addition, a flow-controlled passageway, through which the flow of fluid from the reservoir is delivered to the lumen of the introducer, includes a compliant chamber to hold a reserve of the fluid. Fluid from the reserve may be drawn into the lumen of the introducer as the tunneling tool is withdrawn therefrom. Alternately, the introducer may include a chamber located between two seals, wherein fluid that fills the chamber is drawn distally into the lumen of the introducer, as the tunneling tool is withdrawn therefrom.

Devices for intravascular valve creation and associated systems and methods are disclosed herein.